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Preliminary effectiveness and feasibility of two pre-operative Inspiratory Muscle Training (IMT) interventions in patients undergoing oesophageal resection

Preliminary effectiveness and feasibility of two pre-operative Inspiratory Muscle Training (IMT) interventions in patients undergoing oesophageal resection - Effectiveness and feasiblity of preoperative IMT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33515
Enrollment
60
Registered
2009-07-20
Start date
2009-05-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary infections after oesophagal resection

Interventions

Both IMT interventions will consist of preoperative, individually tailored breathing exercises during 3-6 weeks prior to surgery (i.e. the waiting period for oesophageal resection). The IMT will be

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients selected for oesophagal resection due to cancer

Exclusion criteria

Exclusion criteria: •Neuromuscular disorders that might impede the performance and effects of muscle training •Paresis of facial nerve that might impair the use of the IMT-device •Inability of travelling independently to the rehabilitation centre •Cognitive disorder or emotional instability that might impede the participation in the rehabilitation program •Participation in any other clinical trial that measures quality of life or physical functions (exception: follow-up evaluation of clinical trials)

Design outcomes

Primary

MeasureTime frame
•% pulmonary postoperative complications (i.e. atelectases, pneumonia, pulmonary oedema and respiratory failure, see appendix I)

Secondary

MeasureTime frame
- Maximal inspiratory muscle strength and endurance (Pi max and Pm-peak/Pimax) - % compliance and % adherence rate - Dyspnoea and muscle fatigue (Borg) - Duration of mechanical ventialtion - Number of re-intubations - Diaphragm function - Lung volumes/oxygen uptake, gas exchange - Self-efficacy (ALCOS) - Anxiety (STAY-DI) - Pain (Visual Analogue Scale), dyspnea an muscle fatigue (Borg) - Complications/adverse events

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)